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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / K252229

510(k) cleared

BELLIGER ACE

Genoray Co., Ltd. · Apr 2, 2026 · K252229

FDA cleared the BELLIGER ACE from Genoray Co., Ltd. on Apr 2, 2026 under K252229, a traditional 510(k). The device falls under product code OWB, Interventional Fluoroscopic X-Ray System, regulated at 21 CFR 892.1650 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 16, 2025. The decision came 260 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Genoray Co., Ltd. has one other decision in the tracker over the last 12 months: K250060 (GT300; GT300-C).

Questions & Answers

What did FDA clear under K252229?

K252229 is the FDA 510(k) for BELLIGER ACE, submitted by Genoray Co., Ltd.. FDA's decision date was Apr 2, 2026, under product code OWB (Interventional Fluoroscopic X-Ray System).

Who makes the BELLIGER ACE?

Genoray Co., Ltd., based in Seongnam-Si, is the applicant of record for K252229.

How long did the K252229 review take?

FDA received the submission on Jul 16, 2025 and issued its decision on Apr 2, 2026, 260 days later.

← All decisions in April 2026

Sources